The trial highlighted a 100% sensitivity rate for CRC in the age group of 45-49 years. Credit: Kateryna Kon/Shutterstock.com.

The US Food and Drug Administration (FDA) has granted approval to Geneoscopy’s ColoSense, a noninvasive multi-target stool RNA (mt-sRNA) test for colorectal cancer (CRC) screening in adults aged 45 and older.

The ColoSense test is designed to detect colorectal neoplasia-associated RNA markers and occult haemoglobin in human stool.

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

The test, which is to be used with the ColoSense Collection Kit, Test Kit and Software, as well as specific instruments, is performed at a single site at Geneoscopy.

ColoSense has been designated as a breakthrough device by the FDA and is said to be the first to utilise RNA biomarkers for a dynamic view of disease activity.

The CRC-PREVENT trial, which included participants from diverse backgrounds, showed that ColoSense had a 93% sensitivity for CRC detection and a 45% sensitivity for advanced adenomas (AA) detection in average-risk individuals.

Furthermore, the trial highlighted a 100% sensitivity rate for CRC in the age group of 45-49 years, which is significant for early-age onset CRC prevention.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

Geneoscopy CEO and co-founder Andrew Barnell said: “Securing FDA approval for ColoSense marks a significant milestone for Geneoscopy and demonstrates that our patented RNA technology can provide millions of eligible adults with a safe and effective option for detecting CRC and advanced adenomas.

“This achievement is a testament to our deep dedication and commitment to bringing innovative technology to market that will improve outcomes for this deadly, yet preventable, disease.”

Geneoscopy is preparing for a commercial launch of ColoSense in collaboration with Labcorp, aiming for availability later this year or early 2025.

Last year, the company signed a multi-year agreement with Labcorp for the distribution of the mt-sRNA colorectal cancer screening test.

Medical Device Network Excellence Awards - Nominations Closed

Nominations are now closed for the Medical Device Network Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact

Excellence in Action
SC MEDICA’s minimally invasive, radiation free spinal facet fixation system, FFX® is transforming spinal pain management and improving outcomes for surgeons and patients alike. Learn how SC MEDICA’s award-winning technology is redefining standards in facet joint pain treatment.

Discover the Impact